Gov’t Issues Regulation on Patent Implementation for Remdesivir Medicine

By Office of Assistant to Deputy Cabinet Secretary for State Documents & Translation     Date 26 November 2021
Category: News
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President Joko “Jokowi” Widodo 10 November 2021 has signed   the Presidential Regulation (Perpres) Number 100 of 2021 on the Implementation of Patent Rights by the Government on Remdesivir Medicine. For the record, the regulation can be accessed on this link.

The Regulation states that the spread of COVID-19 has been declared by the World Health Organization (WHO) as a global pandemic and the Government has also stipulated the spread of COVID-19 as a national disaster.

“Considering the urgent need to tackle COVID-19 in Indonesia, it is necessary to stipulate access policy on Remdesivir medicine that is currently still protected by the patent rights,” the Regulation reads.

For the record, based on Law (UU) Number 13 of 2016 (Article 109, Paragraph 3) on Patent Rights amended by Law Number 11 of 2020 on Job Creation, the implementation of patent rights must be stipulated by the Presidential Regulation.

The issuance of the regulation aims to fulfill the medical stock and meet the urgent needs of the treatment of COVID-19.

According to Article 2 of the Presidential Regulation (Perpres) Number 100 of 2021, the implementation of the patent rights will be carried out for three years period. If after that period COVID-19 pandemic has not come to an end, the implementation of patent rights by the Government would be extended until the Government stipulated that COVID-19 pandemic has ended.

In addition to the implementation, it will consist of the name of the active substance, the name of the patent holder, the number of the patent, and the title of the invention.

According to Article 3, the Minister who organizes the Government affairs in health sector appoints the pharmaceutical industry as the patent executor of Remdesivir medicine on behalf of the Government in accordance with the laws and regulations, adding that, the industry carries out duties as limited patent executor in order to meet domestic needs in non-commercial activity.

The industry must meet the requirements, namely having facilities and being able to carry out patent implementation, not being allowed to transfer the implementation of the patent right to other parties, and having a professional way of production, circulation, and supervision (of medical stuffs) in accordance with the laws and regulations.

“The pharmaceutical industry as referred to in Article 3 must provide a reward to patent holders amounting to one percent of the net selling value of Remdesivir medicine,” Article 4 of the Regulation reads.

Furthermore, in Article 5 the reward will be disbursed every year according to the time period.

The Presidential Regulation Number 100 of 2021 has come into force since it was promulgated by Minister of Law and Human Rights Yasonna H. Laoly on 10 November 2021.

The following is the additional appendix to the regulation:

Name of Active Substance Name of Patent Holder Patent Number Title of the Invention
Remdesivir Gilead Sciences, Inc P00201703424/IDP000070932 Methods for Treating Filoviridae Virus Infection
P00201603063/IDP000066850 The Use of Pirolo [1,2,F][1,2,4] Triazina for Treating Sinsitial Respiratory Viral Infection
W00201003923/IDP000034534 The Use of Carba Analogues- Substituted Nucleoside-1’ for Treating Antiviral
W00201300690/IDP000072426

 

Methods and Compounds for Treating Paramyxoviridae Virus Infection

(UN) (AP/LW)

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